A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
NCT ID: NCT06029127
Last Updated: 2026-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2023-10-23
2024-12-31
Brief Summary
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Detailed Description
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Only a portion of patients with advanced solid tumors have a durable response to currently available treatments. This represents an unmet medical need to develop improved therapeutic options. Combining immunotherapies with agents having different mechanism of action might improve outcomes for these patients.
This study was designed as a proof of concept to show that gimistotug-based combination treatment may be able to improve responses and clinical benefit in patients with NSCLC. Treatments in all cohorts was administered up to 36 cycles (approximately 2 years) until participants experienced no benefits, too many side effects, or withdrew consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gimistotug + Docetaxel
Participants received gimistotug and docetaxel 75 mg/m\^2 both by intravenous infusion once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met.
Gimistotug
Administered intravenously
Docetaxel
75 milligrams per square meter (mg/m\^2) administered intravenously
Gimistotug + BGB-15025
Participants received gimistotug by intravenous infusion once every 3 weeks and BGB-15025 orally once daily during each 3-week cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met.
Gimistotug
Administered intravenously
BGB-15025
Administered orally
Interventions
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Gimistotug
Administered intravenously
Docetaxel
75 milligrams per square meter (mg/m\^2) administered intravenously
BGB-15025
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment and a platinum-based chemotherapy administered in combination with, or sequentially before or after the anti-PD-(L)1 treatment
* At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function as indicated by laboratory values during screening
Exclusion Criteria
* Has received prior therapy targeting OX40 or any other T-cell agonists
* Has received prior therapy containing docetaxel and/or ramucirumab for advanced or metastatic NSCLC
* Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before the first dose of study drug(s)
* Active leptomeningeal disease or uncontrolled and untreated brain metastasis
NOTE: Other criteria may apply
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTR20233070
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-LC-203
Identifier Type: -
Identifier Source: org_study_id
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